31995Y1230(06)

COUNCIL RESOLUTION of 20 December 1995 on generic medicinal products (95/C 350/06)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community,

Whereas, in its resolution of 30 November 1995 on the integration of health protection requirements in Community policies, the Council considers that the Community must pay particular attention to the impact on health of action proposed in a number of areas, including free movement of goods;

Whereas action to improve understanding of and address the impact on human health of the free movement of goods, in particular the free movement of medicinal products, should form part of the Community's overall strategy for action in the field of public health;

Whereas matters concerning prices and public financing of medicinal products are the sole responsibility of Member States' authorities;

Whereas generic medicinal products can help bring greater transparency and competition to the market; whereas the use of such medicinal products can improve cost-effectiveness, as emphasized by the Commission in its communication to the Council and the European Parliament of 2 March 1994 on the outlines of an industrial policy for the pharmaceutical sector in the European Community;

Whereas, in its resolution of 19 November 1993 on public health policy after Maastricht, the European Parliament asks the Commission to look into whether it is possible to encourage greater use of generic medicinal products;

Whereas the non-proprietary names of generic medicinal products may make them more easily identifiable;

Whereas it would be very useful for Member States to know the situation regarding generic medicinal products, including branded generics,

CALLS on the Commission, in close cooperation with the Member States, to draw up, in the light of the guidelines in the Annex, a report concerning policy on generic medicinal products in the Member States of the European Union and in the other OECD countries, in particular the USA, Canada and Japan.

ANNEX

Aspects to be considered

1. Collation of existing provisions, including measures to promote the prescription and supply of generic medicinal products.

2. Collation of the technical requirements for the assessment of generic medicinal products, the conditions for registering them and the specific regulations making it easier to obtain marketing authorization for them.

3. Analysis of the impact on public health of price differentials for generic medicinal products as compared with patented products and of the market shares for generic medicinal products.

4. Collation of legislation applicable to the international trade.